Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS UT INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FIORICET W/ CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/30/1992 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2024 | SUPPL-48 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020232Orig1s048ltr.pdf |
12/15/2023 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020232s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020232Orig1s047ltr.pdf | |
03/04/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020232Orig1s045ltr.pdf | |
10/07/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020232Orig1s044ltr.pdf | |
09/18/2018 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf | |
09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf | |
08/29/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020232Orig1s041ltr.pdf | |
12/16/2016 | SUPPL-40 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020232Orig1s040ltr.pdf | |
07/31/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/16/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/18/2013 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf | |
05/09/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf | |
06/22/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020232s033ltr.pdf | |
03/21/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf | |
04/26/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/03/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/22/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/04/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
08/03/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/22/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/20/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/08/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/18/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/29/1994 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/01/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020232s047lbl.pdf | |
03/04/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf | |
10/07/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf | |
09/18/2018 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf | |
09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf | |
08/29/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf | |
12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
12/16/2016 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
10/18/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf | |
05/09/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf | |
06/22/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf | |
03/21/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf |
FIORICET W/ CODEINE
CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 215138 | HIKMA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 076560 | LGM PHARMA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 204649 | STRIDES PHARMA |
FIORICET W/ CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | Yes | AB | 020232 | ACTAVIS LABS UT INC |